Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

not applicable

GLP compliance:

yes

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

25485-88-5

EC Number:

607-733-0

IUPAC Name:

25485-88-5

Constituent 2

Reference substance name:

cyclohexyl salicylate

IUPAC Name:

cyclohexyl salicylate

Test animals

Species:

mouse

Strain:

CF-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

Male mice were individually housed and females were housed 4/cage and given free access to rodent diet and drinking water except for 16 hours prior and 3 hours post dosing of the high-dose group and 4-6 prior to 3 hours post dosing of the other test groups. The animal room had a light photoperiod of 12 hours.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

Peanut Oil

Details on exposure:

8-week-old CFW-1 (Winkelmann) albino mice (7/sex/group) weighing 20-30 g were gavaged with 3000 mg test substance/kg body weight in peanut oil at a dose volume of 10 ml/kg body weight and euthanized at 24, 48, or 72 hours post dosing.

Duration of treatment / exposure:

dose volume of 10 ml/kg body weight and euthanized at 24, 48, or 72 hours post dosing.

Frequency of treatment:

Once

Post exposure period:

24, 48, or 72 hours

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
300 mg/kg
Basis:
nominal conc.

Doses / concentrations 2

Remarks:

Doses / Concentrations:
1500 mg/kg
Basis:
nominal conc.

Doses / concentrations 3

Remarks:

Doses / Concentrations:
3000 mg/kg
Basis:
nominal conc.

No. of animals per sex per dose:

7/sex/group

Positive control(s):

Positive control (20 mg/kg body weight of Endoxan)

Examinations

Tissues and cell types examined:

Bone marrow

Details of tissue and slide preparation:

The smears were fixed in methanol, rinsed with distilled water 2x, stained in 10% Giemsa, rinsed with distilled water, and air-dried. The stained smears were examined by light microscopy to determine the incidence of micronucleated cells per 1000 polychromatic erythrocytes.

Evaluation criteria:

The proportion of polychromatic to normochromatic erythrocytes was assessed by examination of at least 1000 erythrocytes and the number of micronucleated normochromatic erythrocytes was recorded.

Statistics:

Statistical analyses were conducted using the tables of Kastenbaum and Bowman.

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Any other information on results incl. tables

Dose: 300 mg/kg-Effects:no effects. Results:No mortalities; no statistically significant change in number of micronucleated polychromatic erythrocytes or micronucleated normochromatic erythrocytes; no statistically significant change in the ratio of polychromatic to normochromatic erythrocytes compared to vehicle control.

Dose: 1500 mg/kg-Effects:no effects. Results:No mortalities; no statistically significant change in number of micronucleated polychromatic erythrocytes or micronucleated normochromatic erythrocytes; no statistically significant change in the ratio of polychromatic to normochromatic erythrocytes compared to vehicle control.

Dose: 3000 mg/kg-Effects:no effects. Results:No mortalities; no statistically significant change in number of micronucleated polychromatic erythrocytes or micronucleated normochromatic erythrocytes at any of the 3 sampling times; no statistically significant change in the ratio of polychromatic to normochromatic erythrocytes compared to vehicle control.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the test substance did not show any evidence of mutagenic potential when administered orally.

Executive summary:

Under the conditions of this study, the test substance did not show any evidence of mutagenic potential when administered orally.